Greetings, and welcome to the CorMedix, Inc. Second Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Thank you, Mr. Ferry. You may begin.

Good afternoon, and welcome to the CorMedix second quarter 2020 earnings conference call. Leading the call today is Khoso Baluch, Chief Executive Officer of CorMedix. He is joined by Phoebe Mounts, Executive Vice President and General Counsel; and Matt David, Executive Vice President and Chief Financial Officer. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following: any statements other than statements of historical facts regarding management's expectations, beliefs, goals and plans about the company's prospects, including its clinical development program and marketing approval for DEFENCATH in the U.S. and other product candidates; future financial position; future revenues and projected costs and potential market acceptance of DEFENCATH, Neutrolin and other product candidates. More specifically, forward-looking statements includes any statements about our clinical development plans and the timing, cost results and interpretations thereof, projections as to the company's future capital raising and spending and cash position, expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, business development or other transactions, any commercial plans and expectations, market projections for our product candidates and expectations as to manufacturing and product component costs. Actual results may differ materially from these projections or estimates due to a variety of important factors, including, but not limited to, uncertainties related to clinical development, regulatory approvals and commercialization. These risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward-looking statements. And investors should not place undue reliance on these statements. Please note that CorMedix does not intend to update these forward-looking statements, except as required by law. At this time, it is now my pleasure to turn the call over to Mr. Khoso Baluch, Chief Executive Officer of CorMedix. Khoso, please go ahead.

Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's earnings call, we will discuss several topics with you on the overall progress CorMedix is making in bringing DEFENCATH to the U.S. market for its first indication for use as a catheter lock solution for hemodialysis patients to prevent catheter-related bloodstream infections, with subsequent expansion into other indications. Joining me on this call are Phoebe and Matt. The three topics I will cover fall in the regulatory, financing and commercial area. First, as we disclosed several weeks ago, I'm very pleased by the submission to the FDA of the New Drug Application, or NDA, for DEFENCATH was completed in June. This submission was completed using the rolling submission format granted by the FDA, which we started in March. Completing this filing was a major undertaking as the team had to work through the Chemistry Manufacturing and Control information, CMC, and a large volume of data generated due to the size of LOCK-IT-100 trial and the underlying health issues of the hemodialysis patient group. This was the first NDA submitted by CorMedix and our goals, obviously, are to secure acceptance for filing of the NDA submission and then to obtain NDA approval from the FDA. I'm proud of the team at CorMedix for bringing their collective experience to bear and completing a high quality submission. Phoebe will provide more color during this call. We're also pleased to have recently completed an equity financing, consisting of $23 million in gross proceeds, including a full execution of the green show. The proceeds from this financing provides CorMedix the cash needed to continue the preparation required to launch DEFENCATH into the U.S. hemodialysis market following an approval from the FDA. CorMedix is appreciative of the effort from…

Thank you, Khoso. It is a pleasure to be here again to report on our continuing efforts to bring DEFENCATH to the U.S. market and address the continuing need to reduce catheter-related bloodstream infections. As we previously announced, we have requested and been granted by FDA a rolling submission and review of the modules for the New Drug Application, which is intended to expedite the review process for new products intended to address an unmet medical need. The rolling submission was started in March and completed in June. Consistent with the rolling submission and review process, FDA began an ongoing dialogue with us on the submission as it was in progress. As noted by Khoso, we are very grateful for the effort of the CorMedix team in preparing a high quality submission. Now that the submission of modules is completed, the FDA has 60 days from the date of submission of the final module to review the submissions and decide if it is sufficiently complete and in the correct electronic format for substantive review. If the FDA finds the submission complete, it will be accepted for filing. If it is not complete, we will need to provide the missing information and resubmit the NDA. In this submission, we also requested priority review of the NDA. As we previously reported, the DEFENCATH NDA is eligible for priority review as a result of fast track and qualified infectious disease product designation. At the pre-NDA meeting with FDA, we confirmed the eligibility for priority review. If FDA accepts the NDA submission for filing and awards priority review, then the goal for the review period consistent with the Prescription Drug User Fee Amendments or PDUFA, will be six months from the filed date instead of the standard review period of 10 months. It is…

Thanks, Phoebe. I am pleased to be here today to provide my first financial report for CorMedix. The company just filed its report on Form 10-Q for the second quarter and six months ended June 30, 2020. I urge you to read the information contained in this report for a more complete discussion of our financial results. With respect to our second quarter 2020 financial results. Our net loss was approximately $3.8 million or $0.14 per share compared with a loss of $0.7 million or $0.03 per share in the second quarter of 2019. The higher net loss recognized in 2020 compared to 2019 was due to increased expenses related to our preparations for DEFENCATH's commercial launch. We recorded significant increases in both R&D and SG&A expenses. We recognized a tax benefit of $5.2 million in 2020 from the sale of our New Jersey net operating losses compared with a $5.1 million benefit recorded in 2020. Operating expenses in the second quarter of 2020 increased approximately 61% to $8.9 million compared with $5.6 million in the second quarter of 2019. R&D expense increased by approximately 91% to $5.7 million, including a $3.4 million purchase of raw material that will be used in the production of DEFENCATH for sale in the U.S. upon receipt of FDA marketing approval, partially offset by a 12% decrease in other R&D expenses. SG&A expense increased approximately 26% to $3.2 million compared with $2.6 million in the second quarter of 2019. Higher staffing, marketing and insurance expenses were primarily responsible for the increase, partially offset by reductions in several areas, particularly legal and accounting fees. We recorded net cash used in operations during the second quarter 2020 of $0.3 million primarily as a result of the cash received from the sale of our New Jersey NOLs…

Thank you, Matt. As I've stated, our goal is to maximize shareholders' value. Because hemodialysis is a very concentrated payer-provider market, we continue our preparations to commercialize DEFENCATH in the U.S., whether on our own or with a commercial partner or other parties if a favorable transaction is available. All options are on the table and will be evaluated with the maximum – maximizing shareholders' value in mind. We have now stepped up and are focusing a great view of our energy on engaging specifically with the various stakeholders within the dialysis market through direct contact both with the large dialysis providers and with payers, including CMS. This will provide CorMedix a strong foundation required for an efficient and successful launch. Once again, let me remind you that this significant market represents a very large unmet medical need, as today, there is no pharmacological agent approved in the U.S. for the prevention of CRBSI in central venous catheters. I believe that should DEFENCATH be approved by the FDA, it can rapidly become the standard of care in the U.S. So in summary and the key takeaway. What Phoebe and Matt covered with you, hopefully, provide you with the insight into the effort on which we are focused and that are being accomplished over the last 2.5 months. I am pleased about the progress we are making despite challenges imposed by the coronavirus pandemic. I'd like to reemphasize, I'm delighted that the NDA was submitted. We eagerly look forward to the FDA decision on the acceptance for filing and priority review. We are pleased that we successfully completed a financing, bringing several health care-focused institutional investors and building new investment banking relationships. We are continuing to ramp up our outreach efforts and are establishing the foundation required for CorMedix to launch DEFENCATH into the hemodialysis market in the U.S. upon FDA approval. Finally, a reminder that while we are initially focused on the hemodialysis market, we are determined to seek additional indications for DEFENCATH use in catheters for oncology and TPN patients. We've had previous discussions with the FDA on clinical trial design for use as a catheter-lock solution in oncology and TPN patients and are working to develop the protocols with the goal of finalizing the regulatory pathway for reducing catheter-related bloodstream infections in this additional patient groups and executing on these plans on a post-approval basis. In conclusion, updates going forward will be around the key event: FDA decision on acceptance of filing the NDA, including priority review and PDUFA date; NDA approval by the FDA; TDAPA submission; DEFENCATH's launch. I look forward to being able to provide you with material development updates via the CorMedix website, press release and conference call. Thank you for your continued support of CorMedix.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Andrew D'Silva with B. Riley FBR. Please proceed with your question.

Hey good afternoon, thank you very much for taking my question. Just a few quick ones for me. I'm sorry if you mentioned this. I was bouncing between calls. Did you recognize the NDA filing fee during the second quarter? Or what exactly just led to the substantial quarter-over-quarter uptick in R&D? And what should we expect your normalized R&D run rate to be going forward?

Thank you, Andy, for the question. Matt, would you take the questions?

Thank you. I'm sorry. It didn't come across as clearly. Could you please repeat the question?

Yes. Just what was the reason for the sequential uptick in R&D?

Yes. No problem. I think as we mentioned briefly and you'll see in some of the filings that should be posted by now, we had an additional $3.4 million expense that fell under R&D as part of raw materials that are going into – specifically for heparin, that are going into the production of DEFENCATH that we intend to be able to use for commercial supply following an FDA approval.

Okay. So the typical run rate for R&D going forward, we should assume is about $3.4 million lower? And then should your gross margins you assume to be stronger after you get approval for a little bit because of the stocking that you just mentioned?

I think that's fair. We'll be able to provide more detail once we get closer, but I think that's a reasonable way to look at it.

Okay. Great. And then can you just discuss maybe what you're hearing as of late or what needs to take place after you obtain approval for CorMedix to obtain reimbursement for – from CMS? I'm looking for timing. And what can be done in the interim while there is no CMS reimbursement, assuming you have approval?

Yes. So let me answer that, Andy. Thanks for the question. As I had indicated in the prepared remarks, CMS takes on the majority of the patients. And so it's particularly important for us to work with CMS to get reimbursement under the transitional drug add-on payment adjustment called TDAPA. That process starts once you have the NDA approved. And so our plan is, as soon as we get the NDA approval, we would obviously submit for TDAPA reimbursement at the same time that we submit our filing to get the health care common procedure codes that take place. And usually, the process takes about a quarter. They do a quarterly review, so depending exactly on the approval timing, it takes a quarter for CMS to approve it. And then basically, you're able to move forward with that reimbursement.

So theoretically, next year, you could have a midyear reimbursement established with CMS if everything kind of goes to your expectations?

A lot depends on exactly when – what the FDA is going to give us. Are they going to give us a priority review, a standard review? What is the PDUFA date? And as soon as we get clarity on that, that would help provide us the opportunity to guide further in terms of the exact timing when we expect to get then the TDAPA approval. But we need to first get that feedback from the FDA in terms of are we getting a priority review or standard review and what PDUFA date they could think of.

Okay. Fair enough. That makes sense. Thank you very much, congrats on getting the NDA filed and good luck going forward.

Thanks, Andy.

Thank you. Our next question comes from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your question.

Thanks very much for taking my question. So firstly, with respect to the regulatory process, I was wondering if you could comment on, if the DEFENCATH NDA is accorded priority review, does that by definition accord a six month review time frame to the NDA? Or could it potentially be approved in a faster time frame than that? I mean we have seen examples of this kind of thing happening before, but just wanted to clarify whether getting priority review ties into a six month clock or if it could potentially be approved faster?

Thanks, Ram. Phoebe, would you take that?

Sure. Absolutely. Thank you, Ram. That's a good question. Is the – the PDUFA date, which will reflect a six month review goal, if we get a priority review, is the goal. And as you know, the review may occur and the approval may occur faster than that or it can take longer than that. It really depends on how long it takes FDA to work through the information in the NDA. And that's why we put a premium on making sure that we understood FDA's expectations in what they want to see in the NDA, doing those analysis and making sure that the NDA had the information that we wanted to get in there. And so we're hoping that we've helped FDA have an efficient review period, and yet they've review process faster. You're absolutely right. If you go in and look at the review times, you can find priority review for products that takes longer than six months. And you can find standard review times that take a lot shorter than 10 months, so it's purely a reflection on how long it takes the FDA to work through the material.

Okay. And then just to clarify, you have fast track designation but not breakthrough therapy designation? Is that correct?

We have fast track designation as well as qualified infectious disease product designation. Both those designations confer eligibility for priority review. Fast track, because we're developing an indication for use that addresses a life-threatening unmet medical need; and the qualified infectious disease product, because we're addressing antibiotic use and reduction of pathogen that causes serious infections. So we talked to the FDA at our pre-NDA meeting about our intention to request priority review, and FDA agreed we were eligible to make that request.

Okay. And then just on the commercial side, if I may, one item is with respect to what you think the commercial environment is going to look like at the time that you introduce DEFENCATH? And if any of the restrictions that might hypothetically be in place regarding specific kinds of promotional activities, due to COVID-19, would have any impact on your ability to commercialize DEFENCATH effectively? And if you have identified any potential strategies to potentially overcome these considerations? And also, if you could perhaps comment on the sales preparations, specifically, what you expect the sales force composition to look like? What kinds of people you anticipate hiring and their backgrounds? That would be very helpful. Thank you.

Okay, thank you. So in terms of commercial – on the commercial side and taking into account COVID-19, clearly, the situation is evolving. And we will need to look as we get closer to the timing of approval and launch as to what the environment will be as it relates to COVID-19. Clearly, there are restrictions right now in clinics and in centers about individuals entering those places. So clearly, that in itself will have its challenges if it remains into next year. So we're going to closely monitor that, but that would be the only item that I would see that could have an impact. And therefore, our focus is being with a lot of the advocacy groups that I outlined in the prepared remarks that we are finding different ways to begin to communicate both with the health care providers at the labs with those channels to communicate with the health care provider in order to ensure that the message of DEFENCATH gets out. In terms of sales force composition, assuming that we get back to a more traditional model, we have indicated that an organization, no greater than about 50 people, is what would be required that would cover both the sales force, the market access and also medical affairs, would be required to provide the coverage that we need because of the concentration of the providers for hemodialysis, but also the concentration of the payers. And so it is, again, a very concentrated, small organization. And most of those individuals would come onboard closer to the time of approval and launch. So we will clearly be watching the situation raised by your first point on how COVID-19 will take place. Clearly, we're going to look to get individuals that have experience in the hematology space, that would add a lot of benefits in terms of learning curve that one require. So hopefully, that answers your question.

Yes. And then just two very quick financial housekeeping items. Can you confirm that the overallotment was exercised in full in your most recent financing? And then also, do you have any perspectives regarding the time frame within which the Series G preferred stock might be converted to common stock [indiscernible]? Thank you.

Thanks, Ram. Matt?

Yes. I think that for the first part of your question, Ram, we can confirm that the overallotment, the Greenshoe, was executed in full. So we're pleased to be able to share that with you. On the second point, I don't have any information that we can share at this point about the Series G preferred.

Thank you.

Thank you. We have no further audio questions at this time. I'd like to turn the floor over to Mr. Ferry for written questions.

Thank you, operator. So my first one is for Matt. Matt, given your previous cash runway guidance into Q2 2021, can you comment on the timing of the most recent raise?

Sure, no problem. Thank you for the question. As we have said in the past, it is our responsibility to make sure that the company is appropriately capitalized to execute on our plans to commercialize DEFENCATH in the U.S. We don't believe it's a good corporate finance practice to wait until there's just a few months of cash on the balance sheet in order to account for unexpected market turbulence, setbacks and other unexpected circumstances such as COVID-19. Ultimately, our decision is driven by our goals of: one, having sufficient capital to execute on our plans; two, broadening our institutional shareholder base; and three, expanding our investment banking relationship.

Thanks, Matt. I now have one for Phoebe. Phoebe, is there still a risk that the FDA would reject the NDA after filing because there's only a single study?

Thanks, Dan. That's a good question. We think we've derisked the process as much as possible at this point. It should properly now be an NDA review issue, not a filing decision. The acceptance for filing is based on the completeness of the submission to enable a review. The review itself will determine whether there is substantial evidence of safety and effectiveness of DEFENCATH in reducing CRBSIs in hemodialysis patients based on the data in LOCK-IT-100. There are examples of FDA requiring additional clinical data for NDA approval even when there are two pivotal trials based on a review of the information in the NDA. So it's not a completeness issue but a review issue. So we don't think it should be an obstacle for FDA accepting the NDA profiling.

Thanks, Phoebe. And as a follow-up, if you believe that LOCK-IT-100 is sufficient, why request approval under LPAD?

Again, a good question. I think most folks would agree that it's prudent to have alternatives or plan B. I like to think of LPAD as our plan B. Our goal has always been to bring DEFENCATH to the market as fast as possible to help address the unmet medical need. If FDA needs additional flexibility to approve the NDA, which, as we just talked about, is based on a single study, by relying on LPAD, then it will be fulfilling the purpose of LPAD as an – risk in the 21st Century CARES Act.

Thanks, Phoebe. And Khoso, if I might, Khoso, is the partnership still on the table? Are you in active discussions? Did you raise more cash because you don't have an interested partner?

Thanks, Dan, for your question. In terms of a partnership on the table, we have never publicly said that there's any discussion going on. But all options will be evaluated with maximizing shareholder value in mind. And to that effect, we will actively pursue all options, whether on our own or with a commercial partner or other parties if a favorable transaction is available. And clearly, those discussions remain confidential till the moment that we would require to disclose it and it would be appropriate to disclose.

Great. Thank you, Khoso. Operator, that concludes the written questions that I have from the audience.

Thank you. I’d now like to turn the floor back over to Khoso for closing comments.

Thank you, operator. CorMedix has an experienced team of executives that have taken pharmaceutical through the various phases of clinical studies, registration and successfully launched product in the U.S. market. And we remain very committed to bringing DEFENCATH to the U.S. market, as I've said, whether on our own or with a strategic or commercial partner to help patients in need of protection from life-threatening infections. The importance of preventing infections and keeping patients out of hospitals is even more apparent during the ongoing coronavirus pandemic. So please stay tuned as we should have updates from the FDA in the next few weeks. Thank you for your time, attention, and have a good evening. Thank you.

This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.